Apparatus and method for treating gastroesophageal reflux disease

ABSTRACT

A minimally invasive surgical procedure is disclosed which includes the steps forming a fold of tissue, extending one or more needles through the fold of tissue, deploying a tissue fastener from an interior lumen of each of the needles, and retracting each of the needles from the fold of tissue such that the tissue fasteners remain deployed in the fold of tissue.

This application is a continuation of application Ser. No. 10/314,722,filed Dec. 9, 2002, which claims priority from provisional applicationSer. No. 60/342,540 filed Dec. 20, 2001, the entire contents of whichare incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The subject invention is directed to a minimally invasive surgicalprocedure, and more particularly, to an endoscopic surgical procedurefor treating gastroesophageal reflux disease, and apparatus forperforming the procedure.

2. Background of the Related Art

Gastroesophageal reflux disease (GERD) is one of the most commonupper-gastrointestinal disorders in the western world, with a prevalenceof approximately 360 cases per 100,000 population per year.Approximately 25% of individuals with GERD will eventually haverecurrent, progressive disease and are candidates to undergo anti-refluxsurgical procedures for effective long term therapy.

GERD is a condition in which acids surge upward from the stomach intothe esophagus. Backflow of acid into the esophagus makes it raw, red andinflamed, producing the condition known as esophagitis; it also causesthe painful, burning sensation behind the breastbone known as heartburn.Backflow or reflux of acid can occur when the sphincter or band muscleat the lower end of the esophagus fails to stay closed. This sphincteris called the lower esophageal sphincter (LES). The LES acts as a valveto the stomach, remaining closed until the action of swallowing forcesthe valve open to allow food to pass from the esophagus to the stomach.Normally the valve closes immediately after swallowing to preventstomach contents from surging upward. When the LES fails to provide thatclosure, stomach acids reflux back into the esophagus, causingheartburn.

The general approach for corrective surgery involves creating a newvalve or tightening the existing valve. This procedure is known as“fundoplication” and is used to prevent the back flow of stomach acidsinto the esophagus. Various fundoplication procedures have beendeveloped to correct GERD and are known as Nissen fundoplication, BelseyMark IV repair, Hill repair and Dor repair. Each surgical procedure hasits own unique attributes; however, each requires an invasive surgicalprocedure, whereby the individual must endure trauma to the thoraciccavity. The individual remains hospitalized after the procedure forabout six to ten days.

The Nissen fundoplication technique involves enveloping the loweresophagus with the gastric fundus by suturing the anterior and posteriorfundal folds about the esophagus. Modifications of this procedureinclude narrowing of the esophageal hiatus posterior to the esophagus,anchoring of the fundoplication to the preaortic fascia and surgicaldivision of the vegus nerve. The degree of the fundal wrap can bemodified to incompletely encircle the esophageal tube to avoid gas floatsyndrome and has also been modified to include a loose wrap. Similarly,the Belsey Mark IV repair, Hill repair and Dor repair are directed tomodifications for encirclement of the esophageal tube by fascia.

Complications of these fundoplication procedures include the inabilityto belch or vomit, dysphagia, gastric ulcer, impaired gastric emptyingand slippage of the repair that may foil the best surgical results.Therefore, the fundoplication procedures have been modified to adjustthe length and tension of the wrap, include or exclude esophageal musclein the sutures and leaving the vagus nerves in or out of theencirclement.

A relatively new fundoplication technique is known as Nissenfundoplication laparoscopy. In contrast to the traditional Nissenfundoplication procedure, which requires a 6 to 10 inch incision and a 6to 10 day hospital stay with up to 8 weeks of recovery at home, thelaparoscopy technique is performed through small openings about theabdominal cavity and most patients tend to leave the hospital in twodays and can return to work and other activities within a week or two.Despite the benefits of less invasive laparoscopic fundoplicationprocedures, there is still a need for a minimally invasive correctivetreatment for GERD that can be performed on an out-patient basis.

SUMMARY OF THE INVENTION

The subject invention is directed to a new and useful minimally invasivesurgical procedure for treating Gastroesophageal reflux disease byreducing the diameter of the esophagus proximate to the lower esophagealsphincter, and to an endoscopic surgical apparatus for performing theprocedure. The method includes the steps of forming a fold of esophagealtissue proximate to the lower esophageal sphincter, and extending atleast one needle through the fold of esophageal tissue. Each of theneedles has an interior lumen containing a tissue fastener. The methodfurther includes the steps of ejecting a distal portion of the tissuefastener from the interior lumen of each needle such that the distalportion of each tissue fastener is disposed against a distal surface ofthe fold of esophageal tissue, and retracting each needle from the foldof esophageal tissue such that a proximal portion of each tissuefastener is deployed from the interior lumen of each needle and isdisposed against a proximal surface of the fold of esophageal tissue.

The method further comprises the step of providing an endoscopic devicehaving a an interior lumen for supporting the needles in a manner thatpermits the reciprocal movement thereof, and a tissue reception cavityfor receiving the fold of esophageal tissue. The method includes guidingthe endoscopic device through the esophagus to a location wherein thetissue reception cavity is disposed proximate to the lower esophagealsphincter. Thus, the step of forming the fold of esophageal tissueincludes the step of drawing esophageal tissue into the tissue receptioncavity of the endoscopic device. This may be accomplished using suctionor with a tissue grasping device.

Preferably, a tissue fastener of shape memory alloy or a similarbio-compatible material having memory characteristics is provided withinthe interior lumen of each needle in a generally elongate orientation.The step of ejecting a tissue fastener from the interior lumen of aneedle includes permitting the distal portion of the tissue fastener tomove to a normally unstressed condition (at body temperature) whereinthe distal portion of the tissue fastener is in a curved or coiledorientation. The step of retracing the needle from the fold ofesophageal tissue includes permitting the proximal portion of the tissuefastener to move to a normally unstressed condition (at bodytemperature) wherein the proximal portion of the tissue fastener is in acurved or coiled orientation. It is envisioned that the needles may beextended through the fold of esophageal tissue simultaneously or inseriatim. Similarly, the tissue fasteners may be ejected from theneedles simultaneously or in seriatim. After the fasteners have beenejected from the needles, the fold of esophageal tissue is released fromthe tissue reception cavity, and the endoscopic device is withdrawn fromthe esophagus.

The subject invention is further directed to an endoscopic surgicalapparatus for performing the method summarized above. The apparatusincludes an elongated tubular body having opposed proximal and distalend portions and an interior lumen extending therethrough. An endoscopemay be housed within the interior lumen of the tubular body. Preferably,one or more needles are disposed within the elongated tubular body andare mounted for reciprocal movement therein between a retracted positionand a protracted position. Depending upon the configuration andorientation of the needles within the tubular body, it is envisionedthat the reciprocal movement thereof may be either longitudinal,rotational or helical. Each of the needles has an interior lumenextending therethrough. A tissue fastener is disposed within theinterior lumen of each needle. The fasteners are configured for movementbetween an initially straight position within the interior lumen of aneedle and a subsequently coiled or curved position ejected from theinterior lumen of a needle.

A mechanism is provided for effectuating reciprocal movement of theneedle within the interior bore of the elongated tubular body, and amechanism if provided for ejecting the tissue fasteners from theinterior lumen of the needles. Preferably, a tissue receiving window isformed within the distal end portion of the elongated tubular body forreceiving a fold of esophageal tissue. Thus, the retracted position ofthe needle is proximal to or, in some instances lateral to the tissuereceiving window and the protracted position of the needle is distal ofthe tissue receiving window.

These and other aspects of the subject invention and the method of usingthe same will become more readily apparent to those having ordinaryskill in the art from the following detailed description of theinvention taken in conjunction with the drawings described hereinbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

So that those having ordinary skill in the art to which the subjectinvention appertains will more readily understand how to make and usethe surgical apparatus disclosed herein, preferred embodiments thereofwill be described in detail hereinbelow with reference to the drawings,wherein:

FIG. 1 is a perspective view of a surgical apparatus constructed inaccordance with a preferred embodiment of the subject invention;

FIG. 1 a is an enlarged localized perspective view, in partialcross-section, of the distal portion of the surgical apparatus of FIG.1, with parts separated for ease of illustration, wherein the apparatusincludes a plurality of elongated needles mounted for reciprocallongitudinal movement relative to the longitudinal axis of theapparatus;

FIG. 2 is a perspective view of another surgical apparatus constructedin accordance with a preferred embodiment of the subject invention;

FIG. 2 a is an enlarged localized perspective view of the distal portionof the surgical apparatus of FIG. 2, with parts separated for ease ofillustration, wherein the apparatus includes a plurality of curvedneedles mounted for reciprocal rotational movement relative to thelongitudinal axis of the apparatus;

FIG. 3 is a perspective view of another surgical apparatus constructedin accordance with a preferred embodiment of the subject invention;

FIG. 3 a is an enlarged localized perspective view of the distal portionof the surgical apparatus of FIG. 3, with parts separated for ease ofillustration, wherein the apparatus includes a plurality of partiallyhelical needles mounted for reciprocal helical movement relative to thelongitudinal axis of the apparatus;

FIG. 4 is a side elevational view of the distal portion of the surgicalapparatus of FIG. 1 illustrating the formation of a fold of esophagealtissue proximate to the lower esophageal sphincter during a treatmentprocedure;

FIG. 5 is a side elevational view the distal portion of the surgicalapparatus of FIG. 1 illustrating the extension of a needle through thefold of esophageal tissue, wherein the interior lumen of the needlecontains a tissue fastener;

FIG. 6 is a side elevational view the distal portion of the surgicalapparatus of FIG. 1 illustrating the ejection of a distal portion of thetissue fastener from the interior lumen of the needle such that thedistal portion of the tissue fastener is disposed against a distalsurface of the fold of esophageal tissue;

FIG. 6 a is an enlarged localized view of the needle shown in FIG. 6illustrating the ejection of the fastener from the interior lumen of theneedle by the needle pusher;

FIG. 7 is a side elevational view of the distal portion of the surgicalapparatus of FIG. 1 illustrating the retraction of the needle from thefold of esophageal tissue such that a proximal portion of tissuefastener is deployed from the interior lumen of the needle and isdisposed against a proximal surface of the fold of esophageal tissue;and

FIG. 7 a is an enlarged localized view of the needle shown in FIG. 7illustrating the retraction of the needle from the fold of tissue.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to the drawings wherein like reference numerals identifysimilar structural features of the apparatus disclosed herein, there isillustrated in FIG. 1 an endoscopic surgical apparatus constructed inaccordance with a preferred embodiment of the subject invention anddesignated generally by reference numeral 10.

Referring to FIG. 1 in conjunction with FIG. 1 a, endoscopic surgicalapparatus 10 includes an elongated flexible tubular body 12 havingopposed proximal and distal end portions 14, 16 and an interior lumen 18extending therethrough. Elongated flexible needles 20 with taperedleading edges are disposed within the elongated tubular body 12 and aremounted for reciprocal longitudinal movement therein between a retractedposition and a protracted position. More particularly, the elongatedneedles 20 are supported in circumferentially spaced relationship withintubular body 12 by a needle block 25. Needle block 25 is mounted at thedistal end of a tubular drive shaft 27 which is adapted for reciprocalaxial movement within tubular body 12.

Each elongated needle 20 has an interior lumen 22 extendingtherethrough. A tissue fastener 24 formed of a shape memory metal alloy,such as a nickel-titanium alloy, is disposed within the interior lumenof each needle 20. The tissue fastener 24 is configured for movementbetween an initially straight position within the interior lumen of theelongated needle and a subsequently coiled position ejected from theinterior lumen of the elongated needle. In the straight position, and inthe coiled position, opposed end portions 24 a, 24 b of the fastener 24have a generally curved configuration. In FIG. 2 a, the end portion 24 aof fastener 24 is shown in the coiled position, while the opposed endportion 24 b is shown in a transitional state between the initiallystraight position and the subsequently coiled or curved position.

An elongated push rod 26 extends through the interior lumen 22 of eachelongated needle 20 for ejecting at least a portion of the tissuefastener 24 from the interior lumen 22 of the elongated needle 20. Eachpush rod 26 is supported in circumferentially spaced relationship by apush rod block 30. Push rod block 30 is mounted at the distal end of atubular drive shaft 29 which is mounted coaxial with drive shaft 27.Drive shaft 29 is adapted and configured for reciprocal axial motionwithin tubular body 12.

As best seen in FIG. 1, surgical apparatus 10 further includes anactuation mechanism 35 operatively associated with a proximal portion 14of the elongate body 12. Actuation mechanism 35 is adapted andconfigured to effectuate reciprocal longitudinal movement of the driveshaft 27 associated with needle block 25 and the drive shaft 29associated with push rod block 30. It is envisioned that actuationmechanism 35 can take the form of a mechanical actuator, a pneumaticactuator, a hydraulic actuator or an electrical actuator which transmitsforce to the drive shafts 27, 29 through conventional mechanisms, suchas cooperative linkages, gear trains or combinations thereof. It is alsoenvisioned that the fasteners can be fired in a proximal direction.

Surgical apparatus 10 further includes a generally U-shaped or concavetissue receiving window 32 formed within the distal end portion of theelongated tubular body 12. In the retracted position, the elongatedneedles 20 are proximal of the tissue receiving window 32 and in theprotracted position, the elongated needles 22 travel to a position thatis distal to the tissue receiving window 32.

As illustrated in FIG. 1 a, as an option, the surgical apparatus 10 ofthe subject invention could be provided with an angioplasty balloon 40that would be accommodated within an elongated lateral lumen 42. It isenvisioned that angioplasty balloon 40 could be extended from the distalend of tubular body 12 and used as a dilator to increase the esophagealdiameter prior to placement of the fasteners 24.

Referring to FIGS. 2 and 2 a, there is illustrated another surgicalapparatus 110 constructed in accordance with a preferred embodiment ofthe subject invention that includes an elongated body 112 having opposedproximal and distal end portions 114 and 116, and an interior lumen 118extending therethrough. The distal end portion 116 has a tissuereceiving window 132 formed therein and the proximal portion 114 has anactuator handle 135 operatively associated therewith.

As best seen in FIG. 2 a, surgical apparatus 110 includes a plurality ofcurved needles 120 each supporting a surgical fasteners 124 in theinterior lumen 122 thereof. The curved needles 120 are supported inaxially spaced relationship on a needle block 125 that is mounted forreciprocal rotational movement within body portion 112. A plurality ofcurved push rods 126 are supported on a push rod block 130 adjacentneedle block 125. Each push rod 126 is configured to eject at least aportion of a tissue fastener 124 from the interior lumen 122 of a needle120 upon actuation of handle 135. Those skilled in the art will readilyappreciate that conventional mechanisms such as drive screws or driveshafts may be employed to transmit rotational motion from actuationhandle 135 to needle block 125 and push rod block 130.

Referring to FIGS. 3 and 3 a, there is illustrated another surgicalapparatus 210 constructed in accordance with a preferred embodiment ofthe subject invention that includes an elongated body 212 having opposedproximal and distal end portions 214 and 216, and an interior lumen 218.A tissue receiving window 232 is formed in the distal end portion 216and an actuator handle 235 is operatively associated with the proximalpotion 214. As best seen in FIG. 3 a, surgical apparatus 210 differsfrom surgical apparatus 110 in that it includes a plurality of partiallyhelical needles 220 that are mounted for reciprocal helical movementwithin body portion 212 relative to the longitudinal axis of bodyportion 212.

While not shown in FIG. 3 a, a surgical fastener formed from shapememory alloy is supported with the interior lumen 222 of each needle 220and is configured for deployment in the manner described above withrespect to apparatus 110. Those skilled in the art will readilyappreciate that conventional mechanisms such as drive screws or driveshafts may be employed to transmit helical motion from actuation handle235 to the needle block and push rod block operatively associated withcurved needles 220.

The subject invention is also directed to a method of treatinggastroesophageal reflux disease using a surgical apparatus constructedin accordance a preferred embodiment of the subject invention, such as,for example, surgical apparatus 10. Initially, during a surgicalprocedure, the elongated body 12 of surgical apparatus 10 is extendedthrough the esophagus such that tissue receiving window 32 is positionedin a location that is proximate to the esophageal sphincter. Next, asshown in FIG. 4, a fold of esophageal tissue is drawn into the tissuereceiving window 32. This is preferably done under visual observationusing the flexible endoscope 50 extended through the interior lumen 18of body 12, and is preferably accomplished by suction or using a tissuegrasping device such as tissue grasper 45.

Thereafter, one or more needles 20 are extended through the fold ofesophageal tissue, as shown in FIG. 5. At such a time, the distalportion 24 a of the tissue fastener 24 in each needle 20 is ejected fromthe interior lumen 22 of each needle 20 by push rod 26 such that thedistal portion 24 a of each tissue fastener 24 is disposed against adistal surface of the fold of esophageal tissue in a curved condition,as shown in FIGS. 6 and 6 a. Then, as shown in FIGS. 7 and 7 a, needles20 are retracted from the fold of esophageal tissue such that theproximal portion 24 b of each tissue fastener 24 is deployed from theinterior lumen 22 of needle 20 and is disposed against a proximalsurface of the fold of esophageal tissue.

In instances wherein more than one needle is employed, the needles maybe extended through the fold of esophageal tissue either simultaneouslyor in seriatim by staging the needles at different positions relative toone another. Similarly, the tissue fasteners may be ejected from theneedles simultaneously or in seriatim by staging the push rods atdifferent positions relative to one another. After the needles have beenretracted, the fold of esophageal tissue is released from the tissuereception cavity.

Once the fasteners 24 have been deployed, the fold of tissue with whichthey are associated will undergo repetitive movement during peristalsis.Since the ends of the fasteners are curved and flexible, they willadvantageously comply with the fold of tissue as it moves. Thisflexibility also accommodates belching and vomiting. Furthermore, theflexible configuration of the fasteners facilitates the easy removalthereof from the fold of tissue should it become necessary to reversethe procedure. This may be done with a grasping device, such as thatwhich is illustrated in FIG. 4.

Preferably, the steps of the subject invention are performed undervision using an endoscope which may be provided integral with surgicaldevice 10. Alternatively, the treatment method of the subject inventionmay be performed using either ultrasound, fluoroscopy or magneticresonance imaging.

It is also envisioned and well within the scope of the subject inventionthat the surgical apparatus 10 and the method of using the same can beemployed to reduce the volume of a patients stomach. In such aprocedure, gastric tissue would be fastened using the apparatus of thesubject invention. Since the ends of the fasteners utilized in thisprocedure are curved and flexible, they will comply or unfurl with thefold of tissue as the stomach expands with the intake of food.

Although the apparatus and method of the subject invention have beendescribed with respect to preferred embodiments, those skilled in theart will readily appreciate that changes and modifications may be madethereto without departing from the spirit and scope of the presentinvention as defined by the appended claims.

1. A method of treating gastroesophageal reflux disease comprising thesteps of: a) forming a fold of esophageal tissue proximate to the loweresophageal sphincter; b) extending a needle through the fold ofesophageal tissue, the needle having an interior lumen containing atissue fastener; c) ejecting a distal portion of the tissue fastenerfrom the interior lumen of the needle such that the distal portion ofthe tissue fastener is disposed against a distal surface of the fold ofesophageal tissue; and d) retracting the needle from the fold ofesophageal tissue such that a proximal portion of tissue fastener isdeployed from the interior lumen of the needle and is disposed against aproximal surface of the fold of esophageal tissue.
 2. A method accordingto claim 1, further comprising the step of providing an endoscopicdevice having a tissue reception cavity formed in a distal end portionthereof and the step of forming the fold of esophageal tissue includesthe step of drawing esophageal tissue into the tissue reception cavityof the endoscopic device.
 3. A method according to claim 2, wherein thestep drawing esophageal tissue into the tissue reception cavity of theendoscopic device is performed under suction.
 4. A method according toclaim 2, wherein the step of drawing esophageal tissue into the tissuereception cavity of the endoscopic device is performed with a tissuegrasping device.
 5. A method according to claim 2, further comprisingthe step of guiding the endoscopic device through the esophagus to alocation wherein the tissue reception cavity is disposed proximate tothe lower esophageal sphincter.
 6. A method according to claim 2,further comprising the step of providing the needle within an interiorlumen of the endoscopic device.
 7. A method according to claim 6,further comprising the step of providing the tissue fastener within theinterior lumen of the needle in an initial condition wherein thefastener is in a generally elongate orientation and wherein the step ofejecting the staple from the interior lumen of the needle includespermitting the distal portion of the tissue fastener to move to a normalcondition wherein the distal portion of the tissue fastener is in acurved orientation.
 8. A method according to claim 7, wherein the stepof retracting the needle from the fold of esophageal tissue includespermitting the proximal portion of the tissue fastener to move to anormal condition wherein the proximal portion of the tissue fastener isin a curved orientation.
 9. A method according to claim 1, furthercomprising the step of providing an endoscope for performing the stepsof the method under vision.
 10. A method according to claim 9, whereinthe endoscope is provided as an integral part of the endoscopic device.11. A method according to claim 1, further comprising the steps ofextending at least one other needle containing a tissue fastener throughthe fold of esophageal tissue, and deploying the distal and proximalportions of the tissue fastener against respective surfaces of the foldof esophageal tissue.
 12. A method according to claim 11, wherein theneedles are extended through the fold of esophageal tissuesimultaneously and the tissue fasteners are ejected from the needlessimultaneously.
 13. A method according to claim 11, wherein the needlesare extended through the fold of esophageal tissue in seriatim and thetissue fasteners are ejected from the needles in seriatim.
 14. A methodof applying a surgical fastener to gastro-esophageal tissue comprisingthe steps of: a) forming a fold of gastro-esophageal tissue; b)extending at least one needle through the fold of tissue, the at leastone needle having an interior lumen containing a tissue fastener formedfrom shape memory metal disposed in an initial condition; c) ejecting adistal portion of the tissue fastener from the interior lumen of theneedle such that the distal portion of the tissue fastener moves to anormally curved condition against a distal surface of the fold oftissue; and d) retracting the needle from the fold of tissue such that aproximal portion of tissue fastener is deployed from the interior lumenof the needle and moves to a normally curved condition against aproximal surface of the fold of tissue.
 15. A method according to claim14, further comprising the step of providing an endoscopic device havinga tissue reception cavity formed in a distal end portion thereof and thestep of forming the fold of gastro-esophageal tissue includes the stepof drawing tissue into the tissue reception cavity of the endoscopicdevice.
 16. A method according to claim 15, wherein the step of drawingtissue into the tissue reception cavity of the endoscopic device isperformed under suction.
 17. A method according to claim 15, wherein thestep of drawing tissue into the tissue reception cavity of theendoscopic device is performed with a tissue grasping device. 18-29.(canceled)